HER2-positive Breast Cancer Clinical Trial
— SIGHEROfficial title:
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 9000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed every six months for five years.
Status | Recruiting |
Enrollment | 9000 |
Est. completion date | December 15, 2029 |
Est. primary completion date | December 15, 2029 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | For inclusion in the study, patients must be affiliated to the national or local social security, and must meet all the following criteria: Inclusion Criteria: - Age = 18 years - Histological diagnosis of breast adenocarcinoma. Non-metastatic and operable. - Current or prior treatment with one therapy targeting HER2 in adjuvant or neoadjuvant phase for the current breast cancer - Given written informed consent Exclusion Criteria: - Patients not able to comply to the protocol assessments for geographic, social or psychological reasons - Patients placed under judicial protection, guardianship, or supervision - History of cancer in the 5 years preceding anti-HER2 therapy initiation - Concomitant cancer (except for an other non metastatic cancer treated only with surgery) Note : Patients are eligible at any time of the follow-up if the adjuvant or neoadjuvant chemotherapy started after 01/01/2019. Patients treated with trastuzumab, pertuzumab, neratinib or T-DM1 in a clinical trial are eligible in the SIGHER study. |
Country | Name | City | State |
---|---|---|---|
France | Institut de cancérologie Strasbourg Europe | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Institut de cancérologie Strasbourg Europe |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic Complete Response (pCR) | Constitutional genetic variants using a genome-wide approach will be tested for association with pCR as a function of neoadjuvant treatment targeting HER2. | at the end of enrollment (3 years) | |
Primary | Disease Free Survival (DFS) | Constitutional genetic variants using a genome-wide approach will be tested for association with DFS as a function of treatment | At the end of the study (8 years) | |
Primary | Overall Survival (OS) | Constitutional genetic variants using a genome-wide approach will be tested for association with OS as a function of treatment | At the end of the study (8 years) |
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